Device for injecting a controlled dose of solution, relative production method and kit

ABSTRACT

An injection device (100) for the injection of a controlled dose of an injectable substance, including: one containment chamber (33) of the injectable substance, defined inside a tubular body (3); a plunger (5) slidingly engaged inside the tubular body (3), provided with a central stem (53) placed between a cap (51) and a base (52); a spacer applied to the plunger (5) and adapted to allow a forward movement of the plunger (5) in the containment chamber (33) up to reach an abutment of the spacer between the base (52) of the plunger (5) and the second end (32) of the containment body (3) to prevent the further forward movement of the plunger (5) in the containment chamber (33). The injection device (100) is characterized in that the spacer is a flexible dosing label (9), that can be deformed in one longitudinal direction (X) and rigid in one transverse direction (Y).

The present invention relates to a device for injecting a solution, inparticular a syringe provided with an element for controlling thequantity of solution to be delivered.

In the pharmaceutical and medical devices field a very relevant aspectto be taken into account is the correct dosage of the solution to bedelivered. Traditional syringes are provided with a containment chamberwherein the solution to be injected is contained. Typically, the maximuminjectable dose of solution is determined by the volume of thecontainment chamber when the plunger is completely withdrawn. In case alower dose of solution needs to be injected, the user withdraws onlypartially the plunger until the desired dose is contained inside thecontainment chamber, or he withdraws the plunger completely and thenmoves it forward thus expelling the exceeding dose. The measurement ofthe volume of the solution inside the containment chamber is providedsolely by a graduated scale traditionally present on the body of thesyringe, usually made of transparent material.

In the field some tools are known, called spacers, for controlling morecarefully the dose of administrable solution through a syringe. Spacersare elements of pre-established length, arranged around the plunger ofthe syringe. In use, the spacer abuts between the plunger end and theend of the containment body of the syringe, preventing the plunger frommoving further forward. Consequently, only a known portion of the totalvolume of solution contained in the containment chamber is administered,and the quantity of drug to be administered depends on the length of thespacer.

An example of known spacer is disclosed in document EP1559443. Thedevice in EP1559443 is a rigid body composed of two portions joined by ahinge. The device can be closed around the plunger of the syringethrough a snap-lock mechanism. The device is rigid, made of plastic, forexample by injection moulding.

Known spacers have some drawbacks. since they are complex devices,including hinges and snap-lock elements, they require dedicated mouldsresulting in high production costs. Furthermore, applying them on theplunger of the syringe, in case they are assembled directly in thefactory, requires the use of specific expensive and bulky machinery.

The need perceived in the field of injection devices is to haveavailable a syringe provided with an element for controlling thequantity of solution to be delivered which is simple, cheap and easy tobe assembled on the plunger.

The objective of this invention is overcoming the drawbacks of the priorart taking into account the needs of the field.

Such objective is achieved by an injection device provided with anelement for controlling the quantity of solution to be delivered, inform of flexible label.

Furthermore, the solution according to this invention is particularlyadvantageous as the adjustment element in form of flexible label can beeasily applied on the plunger of the injection device through a simplelabeller.

Such objective is achieved by an injection device according to claim 1,a relative production method according to claim 13, and an injection kitaccording to claim 14. Dependent claims disclose preferred oradvantageous embodiments of the device.

The features and the advantages of the injection device according to thepresent invention are apparent by the hereinafter reported disclosure,for exemplary and not limiting purposes, according to the enclosedfigures, wherein:

FIG. 1 shows a front view of an injection device according to thepresent invention, provided with an element for controlling the quantityof solution to be delivered in form of label (hereinafter dosing label);

FIG. 2 shows the injection device of FIG. 1 provided with more than onedosing labels;

FIG. 3 shows a front view of the back face of the dosing label of FIG.1, in a configuration detached from the injection device;

FIG. 4 shows a planar view of the dosing label of FIG. 1, in a planarconfiguration;

FIGS. 5 to 7 show some application steps of the dosing label on theplunger of the injection device, in particular the step of positioningthe dosing label on the plunger, the step of closing the dosing labelaround the plunger, the step of securing it in position around theplunger;

FIG. 8 shows the step of using the injection device provided with adosing label according to the present invention.

Referring to the enclosed figures, and in particular to FIG. 1, aninjection device is indicated with reference number 100.

In the embodiment illustrated in the above described Figures, theinjection device is a syringe.

The injection device 100 includes a tubular containment body 3,extending between one first end 31 that defines a front opening, and onesecond end 32 that defines a back opening 321.

The tubular body 3 is the containment body of the syringe, adapted tocontain one or ore injectable substances.

Preferably, the tubular body 3 is made of glass or of a transparentplastic material or substantially transparent. Preferably, the tubularbody 3 is made in a single piece.

The front opening 31 is adapted to allow the outflow of an injectablesolution.

Preferably, the front opening 31 of the tubular body 3 is closed by aremovable cap 4, adapted to seal the tubular body 3 on the lower partuntil when the injection device 100 is used. In particular FIG. 1 showsthe sterile and ready-for-use injection device 100, wherein the frontopening of the tubular body 3 is closed by the removable cap 4.

Once the cap 4 has been removed, the front opening of the tubular body 3is engageable with a needle adapted to allow injecting the injectablesolution. In particular, when the injection device 100 is ready for theinjection, the needle is in fluid communication with the front openingof the tubular body 3.

The injection device 100 includes at least one containment chamber 33,defined inside the tubular body 3, for containing one injectablesubstance.

The injection device 100 includes one plunger 5 slidingly engaged insidethe tubular body 3.

The plunger 5 includes a central stem 53, provided with one cap 51 onone side, and a base 52 on the opposite side. As clearly shown in FIGS.1-3 and 6-8, the base 52 preferably projects laterally, for exampleradially, from the stem 53. The base 52 is for example a plate,preferably of circular or elliptic shape.

The cap 51, arranged inside the containment chamber 33, is adapted toslide inside the tubular body 3 of the syringe due to a pushing ortraction force exerted by the plunger 5.

Cap 51 is for example made of rubbery and/or plastic material and it issuch as to sealingly engage with the inner walls of the tubular body 3of the injection device 100, and it is such as to be able to slideinside the injection device 100 to allow the outflow of the injectablesolution.

The base 52 of the plunger 5 provides a supporting or grasping point forthe user, for moving forward or backward the plunger 5 with respect tothe tubular body 3 of the injection device 100.

The maximum injectable dose of solution through the injection device 100is determined by the total volume of the containment chamber 33 when theplunger 5 is completely withdrawn. In case a lower dose of solutionneeds to be injected, the user withdraws only partially the plunger 5until the desired dose is contained inside the containment chamber 8, orhe withdraws completely the plunger 5 and then moves it forward thusexpelling the exceeding dose.

In order to control more carefully the administrable dose of solution,the injection device 100 includes one spacer 9.

The spacer 9 is an element of pre-established length L, arranged aroundthe plunger 5, in particular placed around the central stem 53. In use,the spacer 9 abuts between the base 52 of the plunger 5 and the secondend 32 of the containment body 3 of the syringe, preventing the plunger5 from moving further forward inside the containment chamber 33.Consequently, only a known portion of the total volume of solutioncontained in the containment chamber 33 is administered, and thequantity of drug to be administered depends on the length L of thespacer 9.

The injection device 100 includes a spacer in form of flexible label,hereinafter dosing label 9. The dosing label 9 is shown in detail inFIGS. 3-5.

The dosing label 9 is composed of one body 91, preferably ofsubstantially rectangular and elongated shape. The width of the body 91defines the predetermined length L of the spacer.

The body 91 includes a front face 92 and a back side 93. The body 91includes a central portion 910, arranged between two side portions orends 911. The central portion 910 is meant, while the injection deviceis in use, to abut between the base 52 of the plunger 5 and the secondend 32 of the containment body 3 of the syringe.

The dosing label 9 is a strip of flexible material, preferably made ofplastic material.

Advantageously, the dosing label 9 is a simple element to bemanufactured and can be easily applied on the plunger 5 of the injectiondevice 100 by means of a simple labeller.

In one embodiment, the body 91 is a strip of flexible material, that canbe deformed in the longitudinal direction X and rigid in the transversedirection. In other words, it is capable of flexing and closing as inFIG. 5, and capable of enduring the shear strengths as in FIG. 8. Infact, in use, the dosing label 9 abuts between the base 52 of theplunger 5 and the second end of the containment chamber 3 of thesyringe, preventing the plunger 5 from moving further forward inside thecontainment chamber 33.

In one further embodiment, the body 91 is a strip of flexible material,that can be deformed in the longitudinal direction X and rigid in thetransverse direction only at the central portion 910.

Preferably, the central portion 910 is more rigid than the ends 911,though it can always be deformed in the longitudinal direction X toallow the folding of the dosing label 9 as in FIG. 4.

In one example, the central portion 910 is implemented with a thickerbody portion 91, having indeed greater thickness than the ends 911.

In one further example, the central portion 910 is implemented applyinga plastic little bar in the middle of the body 91.

In one embodiment, the dosing label 9 can be plastically deformed inlongitudinal direction, in other words, it maintains a C-form when it isfolded as in FIG. 4.

In one further embodiment, the dosing label 9 can be plasticallydeformed only at the central portion 910, i.e. it maintains a C-formwhen it is folded as in FIG. 4.

The dosing label 9 can be closed as a ring when it is folded. Inparticular, the dosing label 9 can be closed at the ends 911.

The dosing label 9 is at least partially self-adhesive at the back side93. In other words, at the back side 93 of the dosing label 9 a strip ofadhesive material is applied, for example a glue.

In one embodiment, the back side 93 of the dosing label 9 isself-adhesive only at the ends 911 (i.e., the back side 93 of the dosinglabel 9 is free from adhesive material at the central portion 910). Oncethe dosing label 9 is folded in C-form, the ends 911 join between themat the adhesive back side, locking the dosing label 9 on the plunger 5.

In one further embodiment, the whole back side 93 of the dosing label 9is adhesive. Thereby the dosing label 9 sticks on the plunger 5 and inparticular on its central stem 53, at least at the central portion 910.

Preferably, the length (measured along the axis) of the central portion910 of the dosing label 9 is smaller than the circumference of theplunger 5 of the injection device 100.

Such solution facilitates the folding of the dosing label 9 on theplunger 5 when there is a central portion 910 more rigid than the ends911: in fact, in such way the rigid distal edges 913 of the centralportion 910 do not interfere one another during the folding step of thelabel 9.

Such solution allows to glue the dosing label 9 at least partially tothe plunger 5 also in case the central portion 910 is not provided withadhesive: in fact in that way the adhesive proximal edges 914 of theends 911 are joined to the plunger 5 locking the label 9 in position.

Further preferably, the plunger 5 is graduated, i.e. it is provided withnotches 55 at the stem 53 adapted to indicate to the user the correctpositioning wherein the dosing label 9 must be applied.

Further preferably, the stem 53 of the plunger 5 has a circular sectionto facilitate the gluing in position of the dosing label 9.

FIG. 1 shows one injection device 100 provided with a dosing label 9fixed in position on the stem 53 of the plunger 5. The dosing label 9 isfastened in abutment against the base 52 of the plunger 5.

FIG. 2 shows an injection device 100 provided with a plurality of dosinglabels 9 (in particular two dosing labels 9) fastened in series alongthe stem 53 of the plunger 5. One first dosing label 9′ is fastened inabutment against the base 52 of the plunger 5, and one second dosinglabel 9″ is fastened in abutment against the first dosing label 9′. Insuch embodiment, the dosing labels 9 can be removed: once the injectionof one first dose of solution has been performed, the second dosinglabel 9″ is removed in order to allow injecting one further dose ofsolution; it is possible to perform the injection of the residual doseof solution removing also the first dosing label 9′.

FIGS. 5 to 7 show some application steps of the dosing label 9 on theplunger 5 of the injection device 100. FIG. 5 shows the folding step ofthe dosing label 9 along direction X, to perform a C-form (or a U-form),for the following application on the injection device 100.

FIG. 6 shows the closing step of the dosing label 9 around the stem 53:distal edges 915 of ends 911 are joined between them (at the adhesiveback side 93) so as to close the label 9 without preventing it fromsliding along the plunger 5.

FIG. 7 shows a step of locking in position of the flexible label 9around the plunger 53: the dosing label 9 is slided along the stem 53until its abutment against base 52 of the plunger 5; adhesive proximaledges 914 of the ends 911 are joined to the stem 53 so as to glue thelabel 9 firmly in position on the plunger 5.

Advantageously, once fastened in position on the plunger 5, the dosinglabel 9 has a grasping portion 97 at the ends 911 overlapped and gluedbetween them.

FIGS. 7 and 8 show the steps of use of the injection device 100 providedwith a dosing label 9.

FIG. 7 shows an injection device 100 ready to be used: the forwardmovement of the plunger 5 determines the beginning of the delivery ofthe solution contained in the containment chamber 3.

The plunger 5 moves forward until when the dosing label 9 reaches andabutment between the base 52 of plunger 5 and the second end 32 of thecontainment body 3 of the injection device 100.

FIG. 8 shows the injection device 100 at the end of the injection: thefurther forward movement of the plunger 5 in the containment chamber 33,and the further delivery of the solution is in fact prevented by thepresence of the dosing label 9.

Therefore, it is clear that the spacer applied to the plunger 5 isadapted to allow a forward movement of the plunger 5 in the containmentchamber 33 up to reach of an abutment of the spacer between the plunger5 and the second end 32 of the containment body 3, to prevent a furtherforward movement of the plunger 5 in the containment chamber 33.

An object of the present invention is an injection device 100 providedwith at least one dosing label 9 applied on the plunger 5. In such asolution, the dosing label 9 is applied on the plunger 5 during themanufacturing step of the injection device 100 by means of a labeller.

An object of the present invention is also an injection kit including aninjection device 100 and at least one dosing label 9 applicable on theplunger 5. In such solution, the dosing label 9 is applied on theplunger 5 directly by the user when the injection device 100 is in use.

An object of the present invention is also one production method for aninjection device 100, including the step of applying the dosing label 9on the plunger 5 by means of a labeller.

Innovatively, an injection device provided with dosing label accordingto the present invention is easy and cheap to manufacture.

Advantageously in fact, as the dosing label is a flexible label, it iseasy to manufacture with no need for proper moulds.

Further advantageously, as the dosing label is a flexible label, it canbe easily applied on the plunger of the injection device by a simplelabeller.

Without prejudice to the principle of the invention, the embodiments andthe implementation details shall be widely varied with respect to whathas been disclosed and illustrated for non-limiting exemplary purposes,without departing from the scope of protection as defined in theenclosed claims.

1. An injection device (100) for injecting a controlled dose of aninjectable solution, including: a tubular containment body (3),extending between one first end (31) that defines a front opening, andone second end (32); at least one containment chamber (33), definedinside the tubular body (3), for containing the injectable substance;one plunger (5) slidingly engaged inside the tubular body (3), having acentral stem (53) placed between a cap (51) and a base (52), said cap(51) being slidingly arranged inside the containment chamber (33) toallow the outflow of the injectable solution; a spacer applied to theplunger (5) and adapted to allow a forward movement of the plunger (5)in the containment chamber (33) up to reach an abutment of the spacerbetween the base (52) of the plunger (5) and the second end (32) of thecontainment chamber (3) to prevent the further forward movement of theplunger (5) inside the containment chamber (33); characterized in thatthe spacer is a flexible dosing label (9), that can be deformed in onelongitudinal direction (X) and rigid in one transverse direction (Y). 2.An injection device (100) according to claim 1, wherein the dosing label(9) is a strip of flexible plastic material.
 3. An injection device(100) according to claim 1, or wherein the dosing label (9) includes acentral portion (910) placed between two ends (911), and wherein thecentral portion (910) is more rigid than the ends (911), though it canalways be deformed in longitudinal direction (X).
 4. An injection device(100) according to claim 3, wherein the central portion (910) has athickness greater than the thickness of the ends (911).
 5. An injectiondevice (100) according to claim 3, wherein the dosing label (9) iscomposed of a body (91) and the central portion (910) is manufactured byapplying a plastic bar at the middle of the body (91).
 6. An injectiondevice (100) according to claim 3, wherein the dosing label (9) can beplastically deformed in longitudinal direction, i.e., it maintains aC-form when folded.
 7. An injection device (100) according to claim 1,wherein the dosing label (9) can be closed as a ring at the ends (911).8. An injection device (100) according to claim 1, wherein the dosinglabel (9) includes one front face (92) and a back side (93) at leastpartially adhesive.
 9. An injection device (100) according to claim 8,wherein the back side (93) is adhesive only at the ends (911).
 10. Aninjection device (100) according to claim 8, wherein the dosing label(9) includes one central portion (910) placed between the two ends(911), and the length of the central portion (910) is smaller than thecircumference of the plunger (5).
 11. An injection device (100)according to claim 1, wherein the stem (53) of the plunger (5) hascircular section.
 12. An injection device (100) according to claim 1,wherein the base (52) of the plunger (5) projects laterally from thestem (53).
 13. Production method of an injection device according toclaim 1, including the steps of: pre-arranging the tubular containmentbody (3), provided with containment chamber (33), and the plunger (5)slidingly engaged inside the tubular body (3); pre-arranging theflexible dosing label (9); applying the flexible dosing label (9) on theplunger (5) by means of a labeller.
 14. An injection kit for injecting acontrolled dose of an injectable solution, including: an injectiondevice (100), provided with a containment tubular body (3), that extendsbetween one first end (31) and one second end (32); at least onecontainment chamber (33), defined inside the tubular body (3), for thecontainment of the injectable substance; a plunger (5) slidingly engagedinside the tubular body (3), provided with a central stem (53) placedbetween a cap (51) and a base (52), said cap (51) being slidinglyarranged inside the containment chamber (33) to allow the outflow of theinjectable substance; at least one spacer applicable to the plunger (5)and adapted to allow a forward movement of the plunger (5) in thecontainment chamber (33) up to reach an abutment of the spacer betweenthe base (52) of the plunger (5) and the second end (32) of thecontainment chamber (3) to avoid the further forward movement of theplunger (5) in the containment chamber (33); characterized in that thespacer is a flexible dosing label (9), that can be deformed in onelongitudinal direction (X) and rigid in one transverse direction (Y).15. An injection kit according to claim 14, wherein the plunger (5) isgraduated, i.e., it is provided with notches (55) at the stem (53)adapted to indicate to the user the correct positioning wherein thedosing label (9) must be applied.